UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028096 |
|---|---|
| Receipt number | R000032113 |
| Scientific Title | The Association with Geriatric Nutritional Risk Index, ADL, and Clinical Outcomes in Patients on Chronic Hemodialysis. |
| Date of disclosure of the study information | 2017/07/24 |
| Last modified on | 2023/07/11 14:13:54 |
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Basic information
Public title
The Association with Geriatric Nutritional
Risk Index, ADL, and Clinical Outcomes in Patients on Chronic Hemodialysis.
Acronym
The Association with Geriatric Nutritional
Risk Index, ADL, and Clinical Outcomes in Patients on Chronic Hemodialysis.
Scientific Title
The Association with Geriatric Nutritional
Risk Index, ADL, and Clinical Outcomes in Patients on Chronic Hemodialysis.
Scientific Title:Acronym
The Association with Geriatric Nutritional
Risk Index, ADL, and Clinical Outcomes in Patients on Chronic Hemodialysis.
Region
| Japan |
Condition
Condition
End-stage renal disease, Sarcopenia, Hypertension, Dyslipidemia, Diabetes mellitus
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Geriatrics | Orthopedics |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the association with GNRI(Geriatric Nutritional Risk Index) and the ability of walking, which patient can walk by oneself or not, and mortality from all causes in HD patients.
Basic objectives2
Others
Basic objectives -Others
Association with GNRI and the ability of walking
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Can walk by oneself or not.
Key secondary outcomes
Mortality from all causes, Incidence of bone fracture and hospitalization, Change of BBS(Berg Balance Scale), TUG(Timed Up to Go), 10 meter Walking Test, and FIM(Function Independence Measure).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who underwent HD in Sugitagenpakukinen Kouritu Obama Hospital between April 1st 2011 and March 31st 2016.
2.Patients who underwent whole bone densitometry.
3.Age : Not applicable
4.Gender : Not applicable
5.Duration of HD/Primary disease of HD : Not applicable
Key exclusion criteria
1.Patients who, started HD during this observation period, died of senility within 3 months after the HD started.
2.Patients who, started HD before this observation period, died of senility within May 30th 2011.
3.Patients who were read to be ineligible by principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tokuharu Tanaka |
Organization
Sugitagenpakukinen Kouritu Obama Hospital
Division name
Department of Internal Medicine
Zip code
Address
2-2 Oote-cho, Obama-shi, Fukui, Japan
TEL
0770-52-0990
tnktya@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tokuharu Tanaka |
Organization
Sugitagenpakukinen Kouritu Obama Hospital
Division name
Department of Internal Medicine
Zip code
Address
2-2 Oote-cho, Obama-shi, Fukui, Japan
TEL
0770-52-0990
Homepage URL
tnktya@gmail.com
Sponsor or person
Institute
Sugitagenpakukinen Kouritu Obama Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
1. Study Design
Retrospective Cohort Study
2. Key inclusion criteria
1) Patients who underwent HD in Sugitagenpakukinen Kouritu Obama Hospital between April 1st 2011 and March 31st 2016.
2) Patients who underwent whole bone densitometry.
3) Age: Not applicable
4) Gender: Not applicable
5) Duration of HD/Primary disease of HD: Not applicable
3. Observation issue
1)Baseline Characteristics: patient's initials, gender, birth date, height, weight, complication, past history, medical record, medication history.
2) Patient's ADL
3)Biochemical test:Alb, Cre, TP, T-Cho, CRP
4) Whole bone densitometry: lean tissue mass (upper & lower limb)
5) BBS (Berg Balance Scale), TUG (Timed Up to Go), 10 meter walking test, FIM (Functional Independence Measure)
Management information
Registered date
| 2017 | Year | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032113
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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